Ultrasound TFP (Transversalis Fascia Plane) for Analgesia After Iliac Crest Bone Graft Harvest

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02398474

Collaborator

(none)

Enrollment

Location

Arms

42.7

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Iliac crest bone graft harvest is associated with acute pain that can lead to chronic postoperative pain. Local anesthetic infiltration and regional anesthesia could be of interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the associated risk of chronic postoperative pain. In this surgery, local anesthetic infiltration of the iliac crest is associated with a pain reduction compare with placebo.

Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane block) has been recently described. Considering the nerves trajectories, the TFP block is probably anatomically the most appropriate block for analgesia after iliac crest bone graft harvest.

The aim of this study is therefore to assess the benefit of an ultrasound TFP block for analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration Design is prospective, randomized, double blind, controlled study

Condition or Disease	Intervention/Treatment	Phase
Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery	Drug: TFP block ropivacaine Drug: ropivacaine infiltration of the iliac crest bone	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque

Actual Study Start Date :

May 12, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iliac crest bone graft with a TFP block Regional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block	Drug: TFP block ropivacaine
Active Comparator: local anesthetic infiltration of the surgical site. RA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone	Drug: ropivacaine infiltration of the iliac crest bone

Arm

Intervention/Treatment

Experimental: iliac crest bone graft with a TFP block

Regional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block

Drug: TFP block ropivacaine

Active Comparator: local anesthetic infiltration of the surgical site.

RA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone

Drug: ropivacaine infiltration of the iliac crest bone

Outcome Measures

Primary Outcome Measures

Morphine consumption 24 hours after the surgery [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years
Patients scheduled for iliac crest bone graft harvest during upper or lower limb surgery

Exclusion Criteria:

Allergy to ropivacaine, propofol, paracetamol, remifentanil, morphine, cisatracurium, ketoprofene, nefopam
Weight < 50 kg
Pregnancy
Severe psychiatric disorder
Paraplegia or tetraplegia
Spinal anesthesia
Contra indication to ketoprofene: age ≥ 75 years, renal insufficiency (creatinine clearance < 50 ml/min), active gastric ulcer, past of asthma with NSAID
Contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, epilepsy
Contra indication to paracetamol: severe hepatic insufficiency
Severe respiratory insufficiency
Abnormal hemostasis or anticoagulant treatment
Chronic use of morphine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Rennes	Rennes		France

Sponsors and Collaborators

Rennes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT02398474

Other Study ID Numbers:

2014-003383-21

First Posted:

Mar 25, 2015

Last Update Posted:

Nov 13, 2019

Last Verified:

Jul 1, 2019

Additional relevant MeSH terms:

CREST Syndrome

Ropivacaine

Study Results

No Results Posted as of Nov 13, 2019